| CTRI Number |
CTRI/2024/06/069314 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparison between pain perception during giving two percent lignocaine and removal of primary molar by infiltartion, intraligamentary and inferior alveolar nerve block technique in primary and mixed dentition children of aged three to nine years A double blinded randomized controlled trial. |
|
Scientific Title of Study
|
Comparative evaluation of pain perception during two percent lignocaine administration and extraction of primary mandibular molars by infiltration, intraligamentary and inferior alveolar nerve block technique in primary and mixed dentition children aged three to nine years A double blinded randomized controlled clinical trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vitasta Bhausaheb Game |
| Designation |
Post Graduate Student in Pediatric Dentisry |
| Affiliation |
MGVs KBH DENTAL COLLEGE AND HOSPITAL,NASHIK(MUHS) |
| Address |
MGVs K.B.H Dental College And Hospital, first floor, department of Pediatric AND Preventive Dentistry (605),Near Mumbai Agra Highway, Panchavati Nashik Maharashtra 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
9421509009 |
| Fax |
|
| Email |
vitastagame@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swapnil K Patil |
| Designation |
Head of Department |
| Affiliation |
MGVs KBH Dental College And Hospital, Nashik |
| Address |
MGVs KBH Dental College and Hospital, first floor, department of Pediatric and Preventive Dentistry (605), near Mumbai Agra Highway, Panchavati Nashik Maharashtra 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
9545178982 |
| Fax |
|
| Email |
dr.swapnilkpatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swapnil K Patil |
| Designation |
Head of Department |
| Affiliation |
MGVs KBH Dental College And Hospital, Nashik |
| Address |
MGVs KBH Dental College and Hospital, first floor, department of Pediatric and Preventive Dentistry (605), Near Mumbai Agra Highway, Panchavati Nashik Maharashtra 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
9545178982 |
| Fax |
|
| Email |
dr.swapnilkpatil@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGVs K.B.H Dental College and Hospital, first
floor, Department of Pediatric and Preventive
Dentistry(605) |
|
|
Primary Sponsor
|
| Name |
Vitasta Bhausaheb Game |
| Address |
MGVs KBH Dental College and Hospital, First floor, Department of Pediatric and Preventive Dentistry (605), Mumbai Agra Road,Panchavati, Nashik-422003 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vitasta B Game |
MGVs KBH Dental College and Hospital, Nashik |
MGVs KBH Dental College and Hospital, First Floor, Room no 605, Department of pediatric and preventive dentistry panchavati, Nashik
Nashik
MAHARASHTRA |
9421509009
vitastagame@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KBH Dental College - Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inferior alveolar nerve block technique |
Two percent lignocaine is administered and extraction done with inferior alveolar nerve block. |
| Comparator Agent |
Infiltration and intraligamentary technique |
Two percent lignocaine administered and extraction will done by infiltration and intraligamentary technique. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1.Frankle behaviour rating scale class 3 or class 4 i.e co-operative behaviour for dental treatment under local anesthesia
2. Children of age group 3years to 9 years
3. No history of allergic reactions to local anesthesia
4.Mandibular teeth indicated for extraction procedure under local anesthesia
5.Not taking any medication that potentially interfere with pain assessment within 24 hours before the treatment
6. No difficulties in communication
7.Mandibular primary molars which have half radicular physiological resorptions and minimum half completed root development of the permanent teeth germs determined by periapical radiography.
|
|
| ExclusionCriteria |
| Details |
1. No informed consent from parents or patient
2. Patients with allergies to local anesthetics
3.History of significant medical conditions contraindicating use of local anesthesia containing epinephrine
4. Frankle behavior rating scale 1 and 2
5. Teeth indicated for restoration or pulpectomy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain perception during two percent lignocaine administration and extraction procedure is to be determined by infiltration, intraligamentary and inferior alveolar nerve block technique.Evaluation will take through using SEM scale. |
9 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will be conducted in department of pediatric and preventive dentistry. Study will be conducted in children of age group 3 tp 9 years. Total 90 primary mandibular molars fulfilling inclusion and exclusion criteria will be selected for study. Pain during injection will be evaluated by investigator with sound eye motor scale. After injection, extraction procedure will take place and investigator will evaluate the pain perception using sound eye motor scale. Children will be divided into three groups. Group A Infiltration using 2 % lignocaine will be administered and then extraction will be carried out. Group B intaligamentary using 2% lignocaine will be administered and extraction will be carried out. Group C Inferior alveolar nerve block will be administered and extraction will be carried out. Statistical analysis by SPPS version 21. Overall intergroup and intragroup comparision by Anova F test. Randomization by simple randomization by using lottery method. Allocation concealment by SNOSE method . Blinding will be double blinding |